MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Model Number	386803
Medical Device Problem Codes	Retraction Problem (1536); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd cathena safety iv catheter the safety mechanism failed.There was no report of patient impact.The following information was provided by the initial reporter: placed on a patient, when the needle is withdrawn, the safety device is not engaged.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.
Event or Problem Description
It was reported while using bd cathena safety iv catheter the safety mechanism failed.There was no report of patient impact.The following information was provided by the initial reporter: placed on a patient, when the needle is withdrawn, the safety device is not engaged :.
Event or Problem Description
It was reported while using bd cathena safety iv catheter the safety mechanism failed.There was no report of patient impact.The following information was provided by the initial reporter: placed on a patient, when the needle is withdrawn, the safety device is not engaged :.
Additional Manufacturer Narrative
The following field has been corrected: h.6.Imdrf annex a code: a0510 h3 other text : see h10.

• Brand Name: BD CATHENA SAFETY IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15108735
• Report Number: 8041187-2022-00395
• Device Sequence Number: 14506625
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: 00382903868032
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 386803
• Device Catalogue Number: 386803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 08/04/2022; 09/13/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/31/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown